Ostomy bag

ABSTRACT

The invention provides an ostomy bag assembly including an outer bag and an inner bag secured to one side of a flange. The inner bag is removable to facilitate disposal. The flange has a polymeric backing film and a layer of bioadhesive for securing the ostomy bag assembly to the body of a patient. The flange includes an orifice to enable bodily waste to be received by the inner bag. The outer bag is detachably bonded to a first attachment zone on the flange and the inner bag is secured to a second attachment zone on the flange. The outer bag is mounted to the flange by an annular bonding element is formed from a multilayer polymeric material comprising first and second ethylene vinyl acetate layers and a polymeric support layer interposed there between. A method of fabricating ostomy bags is also provided.

FIELD OF THE INVENTION

This invention relates to drainage bag assemblies, such as ostomy bags,for receiving bodily waste, and more particularly to an ostomy bagcontaining a removable inner liner.

BACKGROUND OF THE INVENTION

Ostomy bags for receiving bodily waste from colostomy and ileostomypatients are well known. One of the problems faced by users of ostomybags, particularly colostomy bags, is how to dispose of the contents ofthe bag.

Many known forms of ostomy bag are made from materials that are notbiodegradable and are not easily flushed down a W.C. (that is, a toilet)because of, for example, the buoyancy and relative bulk of the bags.With non-flushable bags, it has been common practice to cut an edge ofthe bag and then deposit the contents of the bag in the W.C. forflushing away, leaving the soiled bag for separate disposal, e.g. byincineration or by wrapping and placing in a waste bin.

One solution to this problem has been to provide ostomy bags made frommaterials that are capable of being flushed down a W.C. and examples ofsuch bags are disclosed in WO 94/12128; EP 0259184; US 2004/0059306; EP0320895; U.S. Pat. No. 5,989,235; GB 2083762; EP 388924; GB 2227668; GB2193925; and WO 2007/085803.

In many cases, the flushable ostomy bag comprises an inner bag which isformed from a material that disintegrates or dissolves in water or isotherwise disposable and a protective outer bag formed from a materialthat is resistant to water. The outer bag can be constructed so as to bereusable several times, means being provided for opening the outer bagto permit removal and replacement of the inner bag or liner. The outerand inner bags may both be attached, directly or indirectly, to anadhesive flange which comprises a layer of a bio-compatible adhesivesuch as a hydrocolloid adhesive to secure the ostomy bag to the body ofthe patient about the stomal opening.

US 2004/0059306 in particular describes several forms of construction oftwo piece ostomy bags in which the inner bag or liner is replaceable anda re-fastenable opening is provided in the outer bag to give access tothe inner bag so that it can be replaced.

U.S. Pat. No. 5,785,695 (Alcare) discloses ostomy appliances comprisinginner and outer bags that are releasably attached to an adhesive flangeby means of mechanical couplings comprising coupling rings havingannular grooves that engage corresponding annular rims on the adhesiveflange to form snap-fit connections.

US 2003/0153883 (Hansen) discloses ostomy appliances comprising anadhesive flange to which is secured a first mechanical coupling ring forthe attachment of an outer bag. An inner bag or liner can also besecured to the first mechanical coupling ring by means of a secondmechanical coupling ring which encircles the mouth of the inner bag andwhich forms a snap-fit connection against the radially inner surface ofthe first mechanical coupling ring.

A problem with ostomy appliances employing coupling rings to connect theinner and outer bags to an adhesive flange is that the coupling ringsalmost invariably make the appliance stiffer and less flexible and henceless comfortable to wear. In addition, where the coupling rings for theinner and outer bags are placed relatively close together, this can makeseparation and replacement of the bags difficult, particularly forpeople with impaired or reduced manual dexterity. A further problem withusing coupling rings is that they will need to be removed prior todisposal of an inner bag down a WC. Not only does this add an additionalpotentially awkward step to the removal and disposal process but it mayalso result in the user's hands coming into contact with fecal waste atthe mouth of the bag.

As an alternative to using mechanical couplings, adhesive bonding hasbeen used to secure the inner and outer bags to the adhesive flange.Examples of ostomy bags making use of adhesive bonding can be found inU.S. Pat. No. 5,865,819 (Hollister) and WO 2004/082452 (Coloplast). U.S.Pat. No. 5,865,819 discloses an arrangement in which the inner and outerbags each have their own separate adhesive flange for direct connectionto the body of the patient.

WO 2004/082452 discloses ostomy bags comprising an adhesive flange forattachment to the body of a patient, and inner and outer bags. The innerand outer bags are each provided with adhesive rings for attachment tothe adhesive flange. In the preferred ostomy bag constructions disclosedin WO 2004/082452, the outer diameter of the adhesive ring of the innerbag is larger than the inner diameter of the adhesive ring of the outerbag and hence there is overlap between the two adhesive rings.

WO 2007/085803 discloses an ostomy bag assembly comprising inner andouter bags secured to an adhesive flange.

SUMMARY OF THE INVENTION

The present invention provides an ostomy bag assembly comprising outerand inner bags secured to one side of a flange; wherein:

the flange comprises a polymeric backing film and a layer of bioadhesivefor securing the ostomy bag assembly to the body of a patient;

the flange has means defining an orifice to enable bodily waste to bereceived by the inner bag;

the outer bag is detachably bonded to a first attachment zone on thepolymeric backing film of the flange by means of an annular bondingelement which is interposed between the outer bag and the firstattachment zone;

the inner bag is secured to a second attachment zone on the polymericbacking film of the flange;

the first attachment zone surrounds the second attachment zone and isnon-overlapping therewith;

the second attachment zone surrounds the means defining the orifice;

the annular bonding element is formed from a multilayer polymericmaterial comprising first and second ethylene vinyl acetate layers and apolymeric support layer interposed therebetween;

the first ethylene vinyl acetate layer has a coating of an ethylenevinyl acetate copolymer adhesive thereon; and

the first ethylene vinyl acetate layer is bonded to the polymericbacking film of the flange by means of the coating of ethylene vinylacetate copolymer adhesive, and the second ethylene vinyl acetate layeris welded to the outer bag.

Particular and preferred embodiments of the invention are as set out inthe claims appended hereto or in the paragraphs below.

The polymeric backing film comprises a layer of polyurethane film.Preferably, the polymeric backing film consists of a single layer ofpolyurethane film. The annular bonding element is formed from amultilayer polymeric material comprising first and second ethylene vinylacetate layers and a polymeric support layer interposed there between.The multilayer polymeric material is typically a coextruded film.

The polymeric support layer is selected from polymers that arecompatible with ethylene vinyl acetate (EVA) (for example, can form astrong bond to the EVA during the coextrusion process) and which aretypically of greater tensile strength than EVA. For example, thepolymeric support layer may be a polyamide or an ethylene/methacrylicacid co-polymer or an ionomeric form thereof. A particular example of amaterial suitable for use as the polymeric support layer is Surlyn®.

The total thickness of the multilayer polymeric material can be, forexample, from 120 micrometers (μm) to 180 μm, more typically from 140 μmto 160 μm, for example approximately 150 μm.

A particular example of the multilayer polymeric material is thePerfecSeal® coated PerfecFlex® medical forming film available fromPerfecseal Limited of Londonderry, Northern Ireland, UK, or itsequivalent.

The coating of ethylene vinyl acetate copolymer adhesive on one side ofthe annular bonding element is bonded to the polyurethane film.Preferably, the bond to the polyurethane film is achieved by means ofheat sealing by the application of heat and light pressure using anappropriately shaped heat sealing tool. By way of example, a temperatureof about 120 degrees C. to about 160 degrees C. may typically be appliedfor a period of about 2 to about 5 seconds.

When the annular bonding element is formed from a multilayer polymericmaterial comprising first and second ethylene vinyl acetate layers and apolymeric support layer interposed therebetween, one of the EVA layersis coated with the ethylene vinyl acetate copolymer adhesive and theother EVA layer is uncoated. The uncoated layer is bonded to the outerbag, for example by means of welding, for example, RF welding.

Preferably, the outer bag is formed from a multilayer polymeric filmcomprising a layer of ethylene vinyl acetate and a layer of polyvinyldichloride or polyvinyl chloride, the ethylene vinyl acetate layer beingbonded to the uncoated EVA layer of the annular bonding element. Morepreferably the outer bag is formed from a multilayer polymeric filmcomprising two layers of ethylene vinyl acetate with a layer ofpolyvinyl dichloride sandwiched there between.

The bond between the annular bonding element and the first attachmentzone on the polymeric backing film of the flange is peelable, forexample, the annular bonding element and the attached outer bag can bepeeled away from the flange using only manual force. Once the outer bagand annular bonding element have been peeled away from the polymericbacking film, it is typically not possible to reattach them to thepolymeric backing film by finger pressure alone as the ethylene vinylacetate copolymer adhesive does not retain any adhesive capability atambient temperature after the two surfaces to which it is bonded havebeen peeled apart.

In order to assist the annular bonding element and attached outer bag tobe peeled away from the polymeric backing film of the flange, theannular bonding element may be provided with one or more tabs. The (oreach) tab may be formed from a polyethylene foam material.

The material from which the outer bag is formed typically issubstantially impermeable to flatus gases and in particular the noxiouscomponents of flatus gases. Preferably therefore, in order to preventthe build up of flatus gases inside the ostomy bag assembly, the outerbag is provided with a flatus gas vent opening covered by a filter,which permits gases to exit the bag but filters out malodorous andnoxious gases. Such filters are well known and need not be describedhere.

In the drainage bags of the invention, the attachment zones for theinner and outer bags do not overlap, and, in this respect, the bagsdiffer from the ostomy bags disclosed in US 2004/0059306 and WO2004/082452, where the attachment zones for the inner and outer bags areshown as overlapping. In the bags of the present invention, the firstand second attachment zones may be contiguous or they may be spacedapart. Preferably, they are spaced apart.

The inner bag is secured by means of adhesive to the second attachmentzone on the flange. The adhesive may be, for example a pressuresensitive adhesive or a non-pressure-sensitive adhesive. The adhesivecan be located on the second attachment zone, or on a ring surroundingthe mouth of the inner bag, or on both. In one embodiment, the inner bagis provided with a ring of adhesive surrounding the mouth of the bag.

The inner bag may be formed from a non-disposable waterproof material ofa type described above for the outer bag, but preferably the inner bagis formed from a material that is biodegradable or disposable, such aspolyvinyl alcohol. For example, the inner bag can be formed from apolymer, such as polyvinyl alcohol, of a type or grade that is slowlysoluble in cold water but is more soluble in hot water. Examples oftypes of polyvinyl alcohol suitable for use in the fabrication of innerbags or liners are described in our earlier application WO94/12128.

In one embodiment, the inner bag comprises an inner layer formed from ahot water soluble grade of polyvinyl alcohol and an outer layer formedfrom a non-woven tissue comprising cold water-soluble polyvinyl alcoholfibres and water-insoluble polymer fibers (for example, cellulosic ormodified cellulosic fibres such as rayon fibers). The inner and outerlayers are preferably secured together at their peripheries.

In another aspect, the invention provides a process for manufacturing anostomy bag assembly comprising outer and inner bags secured to one sideof a flange; wherein:

the flange comprises a polymeric backing film, a layer of bioadhesivefor securing the ostomy bag assembly to the body of a patient, and aremovable protective layer covering the layer of bio adhesive;

the flange has means defining an orifice to enable bodily waste to bereceived by the inner bag;

the outer bag is detachably bonded to a first attachment zone on thepolymeric backing film of the flange;

the inner bag is secured to a second attachment zone on the polymericbacking film of the flange by means of a pressure sensitive adhesive;

the first attachment zone surrounds the second attachment zone and isnon-overlapping therewith;

the second attachment zone surrounds the means defining the orifice;

the first attachment zone is defined by an annular bonding element whichis formed from a multilayer polymeric material comprising first andsecond ethylene vinyl acetate layers and a polymeric support layerinterposed therebetween;

the first ethylene vinyl acetate layer has a coating of an ethylenevinyl acetate copolymer adhesive thereon;

and wherein the first ethylene vinyl acetate layer is bonded to thepolymeric backing film of the flange by means of the coating of ethylenevinyl acetate copolymer adhesive, and the second ethylene vinyl acetatelayer is bonded to the outer bag;

which process comprises, or comprises the steps of:

(a) forming the flange by punching a datum hole in a wafer comprisingthe polymeric backing film, layer of bioadhesive and removableprotective layer;(b) die cutting the annular bonding element from a web of the multilayerpolymeric material;(c) placing the annular bonding element on to the flange so that theannular bonding element is disposed concentrically with respect to thedatum hole;(d) heat sealing the annular bonding element to the flange;(e) bringing into contact with the flange a web of a material from whicha panel of the outer bag is to be formed and welding the said web to aninner edge of the annular bonding element;(f) placing the inner bag on the flange and applying pressure to theretoto bond the pressure sensitive adhesive to the second attachment zone;(g) bringing into contact with the said web a further web of a materialfrom which another panel of the outer bag is to be formed and outlinewelding the webs together so that they form the outer bag and enclosethe inner bag; and thereafter(i) cutting the webs to release the ostomy bag assembly.Prior to die cutting the annular bonding element in step (b), one ormore tabs (for example, formed form a polyethylene foam material) may beattached to the web of the multilayer polymeric material. The annularbonding element with tab attached may then be cut from the web.

After the heat sealing the annular bonding element to the flange in step(d), the flange is preferably turned over and left to cool with theannular bonding element facing downwards, thereby preventing curling.The cooled annular bonding element and flange assembly may then beplaced in a magazine in preparation for the welding step (e).

The process may optionally include a further process step of enlargingthe datum hole to accommodate a defined size of stoma in a patient. Theouter bag may comprise outer and inner pairs of panels welded togetheraround their peripheries, the inner pair of panels serving to provide awaterproof and odour-proof containment for the inner bag and the outerpair of panels serving as a comfort layer. The comfort layer maytypically be formed from a non-woven fibrous material such as anon-woven polyethylene fabric formed from polyethylene fibers.

Further aspects and embodiments of the invention will be apparent fromthe following brief description of the drawings and the detaileddescription below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an ostomy bag assembly according to oneembodiment of the invention. In FIG. 1, internal features of theassembly are shown by means of dotted lines.

FIG. 2 is a side sectional elevation through the upper part of theostomy bag assembly of FIG. 1.

FIG. 3 is an enlarged view of the region A in FIG. 2.

DETAILED DESCRIPTION OF THE INVENTION

The invention will now be described in more detail, but not limited, byreference to the specific embodiments illustrated in the drawings.

Referring now to the drawings, FIGS. 1 to 3 show an ostomy bag assemblyaccording to a first embodiment of the invention. The ostomy bagassembly of FIGS. 1 to 3 comprises an outer bag 2 and an inner bag 4attached to an adhesive flange 6.

The adhesive flange 6 comprises a polymeric backing film 8 which, inthis embodiment is formed from polyurethane and has a thickness ofapproximately 30 μm. Supported on the backing film 8 is a layer 10,approximately 0.6 millimeters (mm) to 0.9 mm thick, of a hydrocolloid.The hydrocolloid adhesive, which may be of conventional type, serves tosecure the ostomy bag to the body of a patient. A siliconized paperrelease layer 12 covers the hydrocolloid adhesive layer and protects theadhesive layer against damage and/or drying out prior to use of the bag.

On the side of the flange opposite to the hydrocolloid adhesive is anarea of the backing film 8 which constitutes a first attachment zone andwhich is designated in FIG. 1 by the dotted line 14. An area of thebacking film which constitutes a second attachment zone is designated inFIG. 1 by the dotted line 16.

The flange has means defining an orifice to enable bodily waste to bereceived by the inner bag. As shown in FIG. 1, the flange has a centralhole 18, the primary purpose of which is to serve as a datum hole foralignment of the various component parts of the ostomy bag assemblyduring manufacture. Arranged around the hole 18 is an array ofconcentric cutting lines 20 which are marked on the surface of thesilicone release layer 12. By way of example, cutting lines are providedfor apertures having diameters of 25 mm, 30 mm, 35 mm, 35 mm, 40 mm, 45mm and 50 mm but cutting lines of different diameters could be usedinstead. In use, the patient or medical professional will select anaperture size to suit the stoma of a particular patient and will thencut along the appropriate cutting line to form the required aperture.

As an alternative, the datum hole may be widened by an additionalcutting step during manufacture to give a range of standard sizeopenings. In many cases, a patient may be able to fit the ostomy bagwith a standard sized opening to the stoma without further cutting theadhesive flange. However, in cases where the patient's stoma does notconform to one of the range of standard openings, the patient can selectthe nearest undersized standard opening and then trim it to fit aroundhis or her stoma.

It will be appreciated from the foregoing that the “means defining anorifice to enable bodily waste to be received by the inner bag” can takethe form of an orifice or hole per se or can take the form of markings,score lines, perforations or skip cuts that indicate where a section ofthe flange may be removed to form or enlarge an opening.

The outer bag 2 is detachably bonded to the first attachment zone 14 onthe polymeric backing film 8 of the flange by means of an annularbonding element 22 which is interposed between the first attachment zone14 and the outer bag.

The annular bonding element is shown in more detail in the enlarged viewprovided in FIG. 3. As can be seen from FIG. 3, the annular bondingelement comprises a co-extruded multilayer polymeric material which, inthe particular embodiment illustrated, consists of a central layer 24 ofSurlyn sandwiched between two layers 26 and 28 of ethylene vinylacetate(EVA). One of the EVA layers has a layer of an EVA copolymer adhesiveemulsion 30 coated onto it: the other EVA layer is uncoated. The EVAadhesive-coated co-extruded multilayer polymeric material can be, forexample, PerfecSeal coated PerfecFlex medical forming film availablefrom Perfecseal Limited of Londonderry, UK.

The outer bag 2 is firmly bonded to the uncoated EVA layer 28 bywelding, for example, by radio-frequency (RF) welding. This ensures asecure bond between annular bonding element and outer bag which cannotbe disrupted without tearing the fabric of the outer bag.

The EVA adhesive-coated layer 26, 30 of the annular bonding element 22is bonded to the first attachment zone 14 by aligning the bondingelement 22 in the area of the attachment zone and applying heat with anannular heat sealing tool at a temperature of about 120 degrees C. toabout 160 degrees C. for a period of about 2 to about 5 seconds. The EVAadhesive functions as a hot melt adhesive that forms a bond which,whilst easily strong enough to withstand any forces to which it issubjected during use, can be peeled apart using reasonable manual forceto separate the outer bag from the adhesive flange. Once peeled away,the outer bag and annular bonding element cannot be reattached to theattachment zone without heat sealing since the EVA adhesive does nothave any significant adhesive capability at room temperature andpressure.

In order to assist the annular bonding element 22 to be peeled away fromthe adhesive flange, a tab 29 is provided. The tab 29 is formed from 0.6mm thick polyethylene foam coated on one side with a pressure sensitiveadhesive to secure it to the annular bonding element 22.

Disposed within the outer bag 2, is an inner bag or liner 4. The innerbag or liner 12 is provided with a ring of pressure sensitive adhesive(not shown), which bonds to polyurethane backing film 8 flange at thesecond attachment zone 16.

The outer bag 2 in this embodiment can be formed from materials wellknown for the construction of ostomy bags. Thus, for example, it can beformed from a tough, flexible, transparent, waterproof material such aspolyvinyl dichloride (PVDC), ethylene vinyl acetate (EVA), relatedmaterials and combinations thereof in known fashion, one particularmaterial being the EVA/PVDC/EVA film available from Sealed Air of SaddleBrook, N.J., US under the trade name Cryovac MF514, or its equivalent.

In the embodiment shown, the outer bag is formed from a pair of sheets 2a and 2 b of the flexible waterproof material, one sheet 2 a being cutso as to form an opening, the edge of which is welded to the annularbonding element, and the other sheet 2 b having the same outerperiphery, but no opening. The two sheets are secured together aroundtheir respective peripheries by welding, (for example, by RF welding) orby means of adhesive. Attached to the sheets 2 a and 2 b by weldingaround their respective peripheries are panels 32 a, 32 b formed from afibrous non-woven material, such as, a non-woven polyethylene fabric.The panels 32 a and 32 b serve as a comfort layer, providing a warmerand less harsh feeling against the skin of the patient.

The polymeric materials from which the sheets 2 a and 2 b are formed actas a barrier to gases, and in particular flatus gases. Therefore, inorder to prevent ballooning of the ostomy bag through the build up offlatus gases inside the bag, the outer bag is provided with a smallopening 36 covered by a flatus filter 34 which is welded to both thesheet 2 b and the panel 32 b.

The inner bag 4 is formed from two pairs of sheets 38 a, 38 b and 40 a,40 b of polymeric material, welded together along their peripheries. Theinner pair of sheets 38 a and 38 b is formed from a mechanically toughwarm water soluble grade of polyvinyl alcohol film, for example, a“Solublon EF” (Trade Mark) film available from Aichello, Japan, or itsequivalent. The outer pair of sheets 40 a, 40 b is formed from a fibrousnon-woven tissue formed from cold water soluble polyvinyl alcohol fibresand rayon fibres, which disintegrates in water.

In use, fecal material from a stomal opening passes through the opening18 (enlarged where necessary) in the flange and into the interior of theinner bag or liner 4. When the inner bag or liner 4 is full, the outerbag 2 and the attached annular bonding layer 22 are peeled away from theflange. The flange and inner bag may then be disposed of by flushingdown a W.C. (that is, a toilet) and the outer bag disposed of throughnormal domestic waste channels. A new assembly of inner and outer bagand adhesive flange may then be applied to the patient.

Because the inner bag is formed from materials that are soluble ordisintegrable in water, and the hydrocolloid adhesive of the flange isalso soluble or erodible in water, the sub-assembly of flange and innerbag rapidly disintegrates during flushing leaving as a residue only thethin polyurethane backing film 8 and rayon fibers from the sheets 40 aand 40 b.

The ostomy bag assembly of the invention can be manufactured by alargely automated production process requiring relatively little manualintervention.

Wafers or blanks which will become the adhesive flange 6 are die cutfrom sheets of a trilaminar material consisting of the polyurethanebacking film 8, hydrocolloid adhesive 10 and siliconised paper 12. Thewafers can be prepared off site or manufactured in situ. The wafers areloaded into a magazine and are transferred on a rotating carousel to acutting station where a datum hole 18 is die cut in the centre of thewafer. The hole 18 serves as the datum point for the alignment of thevarious components of the ostomy bag assembly later in the manufacturingprocess.

In a separate operation, polyethylene foam tabs are applied to a web ofa coextruded multilayer film consisting of Surlyn® sandwiched betweentwo layers of ethylene vinylacetate (EVA), one of which is coated with alayer of an EVA copolymer adhesive emulsion. The tabs are bonded to theweb by means of a pressure sensitive adhesive. Rings of the multilayerfilm with a tab attached are then die cut from the web to form theannular bonding elements 22.

The annular bonding elements 22 are then automatically conveyed toanother work station where they are placed over an adhesive flange waferso that the annular bonding element is concentric with the datum hole 18in the wafer. Heat and pressure are then applied to the annular bondingelement to form a heat seal between the annular bonding element and thepolyurethane backing film of the bonding element.

Once the heat seal has been created, the sub-assembly of adhesive flangeand annular bonding element is removed, turned over and placed on a trayto cool with the annular bonding element facing down so as to preventcurling.

After cooling, the adhesive flange-annular bonding elementsub-assemblies are loaded into a magazine with the annular bondingelement facing up and transferred to a separate machine for creating theostomy bags.

In a first step in the creation of the ostomy bags, a first web of anon-woven fabric (from which comfort panel 32 a is made) is die cut toform a series of circular holes. A second web, which is formed from anEVA/PVDC/EVA film (which will become panel 2 a) is then die cut with aseries of holes of a smaller diameter than the holes in the first web.The first and second webs are then secured together by means ofperipheral tack welds.

Adhesive flange-annular bonding element sub-assemblies are thentransferred from their magazine to a welding station where they aresuccessively welded to the second web so that each sub-assemblysurrounds one of the holes in the web.

The first and second webs carrying the adhesive flange-annular bondingelement sub assemblies pass through a further processing station wherepre-formed inner bags, each having an opening surrounded by a ring ofpressure sensitive adhesive, are affixed to the annular bondingelements.

At a separate filter welding station, a third web of material, fromwhich the panel 2 b will be formed, and a fourth web of material, fromwhich the panel 32 b will be formed, are brought together and a filter34 is welded to the surface of the third web. The welding operation iscarried out for a period of time sufficient to ensure that the fourthweb is also welded to the third web in the region of the filter. Theregion over the filter where the third and fourth webs are weldedtogether is then perforated to form an exit hole for flatus gasespassing through the filter.

Once the filter has been affixed, the first, second, third and fourthwebs are passed through another welding station where the four webs areoutline welded together (the outline of the weld defining the shape ofthe ostomy bag). The webs are then cut around the outer edge of theoutline to release the completed ostomy bag assembly from the webs. Thecompleted ostomy bag assemblies may then be inspected and packed.

During the assembly of the ostomy bag, a further and optional cuttingstep may be employed in which the datum hole is enlarged to a sizesuitable for fitting about a stomal opening. During this step,differently sized cutters may be used for different batches therebyenabling the creation of a range of ostomy bags with different sizes ofopening.

EQUIVALENTS

It will readily be apparent that numerous modifications and alterationsmay be made to the specific embodiments of the invention described abovewithout departing from the principles underlying the invention. All suchmodifications and alterations are intended to be embraced by thisapplication.

1-8. (canceled)
 9. A process for manufacturing an ostomy bag assemblycomprising outer and inner bags secured to one side of a flange;wherein: the flange comprises a polymeric backing film, a layer ofbioadhesive for securing the ostomy bag assembly to the body of apatient, and a removable protective layer covering the layer ofbioadhesive; the flange has means defining an orifice to enable bodilywaste to be received by the inner bag; the outer bag is detachablybonded to a first attachment zone on the polymeric backing film of theflange; the inner bag is secured to a second attachment zone on thepolymeric backing film of the flange by means of a pressure sensitiveadhesive; the first attachment zone surrounds the second attachment zoneand is non-overlapping therewith; the second attachment zone surroundsthe means defining the orifice; the first attachment zone is defined byan annular bonding element which is formed from a multilayer polymericmaterial comprising first and second ethylene vinyl acetate layers and apolymeric support layer interposed therebetween; the first ethylenevinyl acetate layer has a coating of an ethylene vinyl acetate copolymeradhesive thereon; and wherein the first ethylene vinyl acetate layer isbonded to the polymeric backing film of the flange by means of thecoating of ethylene vinyl acetate copolymer adhesive, and the secondethylene vinyl acetate layer is bonded to the outer bag; wherein theprocess comprises the steps of: (a) forming the flange by punching adatum hole in a wafer comprising the polymeric backing film, layer ofbioadhesive, and removable protective layer; (b) die cutting the annularbonding element from a web of the multilayer polymeric material; (c)placing the annular bonding element on to the flange so that the annularbonding element is disposed concentrically with respect to the datumhole; (d) heat sealing the annular bonding element to the flange; (e)bringing into contact with the flange a web of a material from which apanel of the outer bag is to be formed and welding the said web to aninner edge of the annular bonding element; (f) placing the inner bag onthe flange and applying pressure thereto to bond the pressure sensitiveadhesive to the second attachment zone; (g) bringing into contact withthe said web a further web of a material from which another panel of theouter bag is to be formed and outline welding the webs together so thatthey form the outer bag and enclose the inner bag; and thereafter (i)cutting the webs to release the ostomy bag assembly.
 10. A processaccording to claim 9, wherein the polymeric backing film comprises alayer of polyurethane film, and the said coating of ethylene vinylacetate emulsion adhesive is peelably bonded to the polyurethane film.11. A process according to claim 10, wherein the polymeric backing filmconsists of a single layer of polyurethane film.
 12. A process accordingto claim 9, wherein the outer bag is formed from a multilayer polymericfilm comprising a layer of ethylene vinyl acetate and a layer ofpolyvinyl dichloride or polyvinyl chloride; and wherein the ethylenevinyl acetate layer is bonded to the first attachment zone.
 13. Aprocess according to claim 12, wherein the multilayer polymeric filmcomprises two layers of ethylene vinyl acetate with a layer of polyvinyldichloride sandwiched therebetween.
 14. A process according to claim 9,wherein the first and second attachment zones are spaced apart.
 15. Aprocess according to claim 9, wherein the inner bag is formed from abiodegradable material or a material that dissolves and/or disintegratesupon flushing down a W.C.